Regulations Affecting Pharmacy Technicians – Comprehensive Study Notes

Lecture Objectives

• Review regulatory standards related to pharmacy practice.

• Review Federal and State statutes governing pharmacy.

• Indicate responsibilities of the State Board of Pharmacy.

• Review the Code of Ethics for Pharmacy Technicians.

• Review patients’ rights and responsibilities.

• Provide an update on major changes affecting pharmacy technicians and assistants.

• Review specific duties and responsibilities of pharmacy technicians.

Rationale for Pharmacy Regulations

• Ensure the orderly and safe functioning of society while protecting individual rights.

• Provide assurance of the safety and welfare of healthcare recipients.

• Establish standards by which courts can judge reasonable and prudent practice.

Legal Foundations: Statutes

• Statutes are enacted by legislative bodies (Congress or state legislatures) and dictate conduct.

• Two key federal statutes:

  • Food, Drug, and Cosmetic Act (FDCA).

  • Comprehensive Drug Abuse Prevention and Control Act (Controlled Substance Act, CSA).

Federal vs. State Drug‐Control Laws

• Practitioners must comply with both federal and state laws.

• Rule of stringency: follow whichever law (state or federal) is more stringent.

• Pharmacists share equal responsibility for compliance with both sets of laws.

State Board of Pharmacy: Responsibilities

1. Ensure the public is well served professionally by pharmacists.

2. Ensure drugs distributed/dispensed meet standards of purity, potency, and proper labeling.

3. Additional responsibilities:

   • Licensure & registration of pharmacies.

   • Handling complaints of professional misconduct.

   • Conducting disciplinary proceedings.

   • Regulating filling/refilling of prescriptions (oral & written).

   • Governing generic/therapeutic substitution.

   • Labeling standards.

   • Pharmacy inspections.

   • Poison schedules management.

Code of Ethics for Pharmacy Technicians (American Association of Pharmacy Technicians)

Preamble

• Pharmacy technicians are healthcare professionals assisting pharmacists to deliver optimal patient care.

• Ethical principles guide interactions with patients, other health professionals, and society.

Ten Principles

1. Primary consideration: ensure patient health & safety; apply knowledge & skills competently.

2. Support/promote honesty & integrity; obey laws; maintain high moral/ethical conduct.

3. Assist pharmacists in safe, efficacious, cost-effective distribution of health services/resources.

4. Respect & value abilities of pharmacists, colleagues, and other healthcare professionals.

5. Maintain competency; continually enhance knowledge & expertise.

6. Respect and support patient individuality, dignity, and confidentiality.

7. Safeguard patient records; disclose information only with proper authorization.

8. Never aid in dispensing/promoting/distributing sub-standard medications or devices.

9. Avoid activities that discredit the profession; expose illegal/unethical conduct without fear or favor.

10. Associate with and support organizations that advance the pharmacy profession and technician role.

Patient’s Rights of Expectation

• Protection from unwanted discomfort due to drug therapy.

• Information on side effects, drug interactions, and preparations for expected/unexpected outcomes.

• Vigilant assurance of reasonable safety in drug therapy.

• Professional service and pharmaceutical expertise with every dispensed drug.

• Complete, comprehensible, up-to-date information on each drug.

• Maintenance of confidentiality.

Patient’s Responsibilities

• Provide complete and accurate medical information.

• Comply with directions provided.

• Communicate unfavorable signs/symptoms after therapy begins.

• Ask questions when instructions are unclear.

Washington Administrative Code (WAC) 246-901: Major Changes Affecting Ancillary Personnel

Background

• 1998 legislation amended rules for pharmacy ancillary personnel; rules effective $\text{August } 19$.

• Goal: give pharmacists flexibility to redistribute responsibilities, allowing more direct patient care time.

Terminology Updates

• "Level A Pharmacy Assistants" ➜ Pharmacy Technicians.

• "Level B Pharmacy Assistants" ➜ Pharmacy Assistants.

• Collective term: Ancillary Personnel.

Registration & Training

• Pharmacy assistants must register with the Board of Pharmacy.

• All technician/assistant applicants must complete $4$ clock-hours of AIDS education (WAC 246-12, Part 8).

• Training programs must be resubmitted for Board approval every $5$ years.

• Board may approve a national voluntary certification exam as the final exam for technician programs.

Prohibited / Permitted Tasks for Pharmacy Assistants

• Prohibited: entering new medication orders in the computer; selecting drug products.

• Permitted: "count & pour" drugs for individual prescriptions.

English Proficiency for Foreign Graduates

• Non-native English speakers must score $50$ on the Test of Spoken English (TSE).

• Mirrors requirements for foreign pharmacy graduates seeking pharmacist licensure.

Pharmacist-to-Technician Ratio

• Standard ratio: $3:1$ (three technicians per pharmacist) in all practice settings.

• Pharmacies may petition the Board via a Pharmacy Services Plan for higher ratios; pilot/demonstration projects may receive conditional approval.

Immediate Supervision Defined

• "Immediate supervision": visual and/or physical proximity to a licensed pharmacist sufficient to ensure patient safety.

Elimination of Grandfather Clause

• Former allowance for assistants with $1040$ hours to be licensed without further training expired $\text{May } 28, 1977$ and has been removed.

Pharmacy Technician Specialized Functions (WAC 246-901-100)

• Technicians meeting criteria (employment, experience, training, demonstrated proficiency) may perform specialized duties.

• Pharmacy’s utilization plan must specify criteria; training/proficiency records must be retrievable within $72$ hours upon Board request.

Approved Specialized Functions

1. Unit-Dose Medication Checking

   • After pharmacist verifies drug order, a technician may check unit-dose cassettes filled by another technician or intern for facilities licensed under chapters $70.41$, $71.12$, $71A.20$, or $74.42$ RCW.

2. Intravenous (IV) Admixture / Parenteral Preparation

   • Technician may prepare IV admixtures and other parenteral drugs.

   • A pharmacist must check each parenteral product prepared.

General Duties of Pharmacy Technicians

Prescription Preparation (under pharmacist supervision)

• Accept written prescriptions from patients or representatives (new phone prescriptions must be handled by a pharmacist).

• Check prescriptions for completeness & accuracy.

• Prepare prescription labels.

• Locate, count, pour, weigh, measure, and mix medications.

• Reconstitute medications.

• Select appropriate prescription containers.

• Affix labels; price and fill prescriptions.

• Establish & maintain patient profiles.

• Repackage and label medications.

Technical / Support Activities

• Maintain packaging & dispensing equipment.

• Replenish medications for nursing units, night cupboards, emergency kits, crash carts.

• Prepare IVs and other solutions using aseptic technique.

• Clean and maintain equipment.

Administrative Duties

• Prepare & reconcile third-party billings (Third-Party Administration, TPA).

• Generate receipts, invoices, letters, memoranda.

• File documents.

• Generate & maintain written/computerized medication records & reviews.

• Maintain drug information files.

• Bill other departments; perform basic bookkeeping/accounting.

• Operate cash register.

Communication Duties

• Interact with customers, physicians, suppliers.

• Refer prescription or drug-information questions to the pharmacist.

• Send/receive electronic communications (e.g., modem, email).

Inventory Duties

• Monitor stock levels; receive & verify purchased supplies.

• Issue supplies; restock medications & materials.

• Maintain storage facilities & inventory records, including controlled substances.

• Rotate stock; monitor expiration dates.

• Identify & retrieve expired items for disposal/destruction/return.

• Repackage medications (including unit-dose) and deliver to wards.

Emerging Issues: "Pharmacy Technicians—Time for Change?"

• Technicians’ roles are expanding, yet nationally the occupation lacks uniform standards for:

  • Education and training.

  • Regulation/licensure across state boards.

• Significant diversity exists among state regulatory requirements.

Introduction to Pharmacy Law

Common Abbreviations

• RCW: Revised Code of Washington.

• WAC: Washington Administrative Code.

• DEA: Drug Enforcement Administration.

• EOC: Easy-Open Cap.

• OTC: Over-The-Counter.

Liability

• Liability: legal responsibility (criminal or civil) to discharge an obligation.

• Pharmacists are liable for technicians’ actions; technicians must not exceed legally allowed scope of practice.

• Prescriptive authority in Washington is dictated by a provider’s scope of practice.

Key Federal Laws & Amendments

1. Food, Drug, and Cosmetic Act (FDCA) $1938$

   • Manufacturers must prove safety & efficacy under labeled conditions.

   • Prohibits misbranded/adulterated foods, drugs, devices, cosmetics.

   • Enforced by FDA; governs quality, strength, purity, labeling.

2. Omnibus Budget Reconciliation Act (OBRA) $1990$

   • (Mentioned as an organization affecting law; mandates DUR and counseling requirements.)

3. Controlled Substance Act (CSA)

   • Comprehensive federal drug policy regulating manufacturing, importation, possession, use, and distribution of controlled substances.

Durham-Humphrey Amendment (DHA) $1951$

• Establishes prescription (legend) vs. OTC classes.

• Requires legend drugs to be dispensed only on prescription of an authorized prescriber.

Kefauver-Harris Amendment (KHA) $1962$

• Manufacturers must prove drug efficacy to FDA before marketing.

• Triggered by thalidomide tragedy.

Poison Prevention Packaging Act $1970$

• Household substances must be in child-resistant packaging.

Prescription Requirements

• Though specified for controlled substances, principles apply to non-controlled prescriptions as well (accurate patient info, drug name, strength, dosage form, directions, prescriber signature, date, refills, etc.).

Summary: Technician’s Ethical–Legal Framework

• Pharmacy technicians function within an evolving, highly regulated environment designed to safeguard patient health.

• Adherence to state/federal statutes, Board regulations, and a robust Code of Ethics ensures safe, effective, and ethical pharmaceutical care.

• Continuous education, competence maintenance, and respect for patient rights form the cornerstone of exemplary technician practice.